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Parkinson DiseasePhase 1Engage-PDNCT04922190

Promoting Physical Activity Engagement for People With Early-mid Stage Parkinson's Disease (Engage-PD)

A Phase 1 study testing Physical Activity Coaching in people with Parkinson Disease, run by Teachers College, Columbia University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Engage-PD is a single cohort evaluation of implementation of a telehealth-delivered physical activity coaching program for people with early-mid stage Parkinson's disease. The program utilizes a physical or occupational therapist to provide one-on-one coaching for individuals with early-mid stage Parkinson's disease… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Parkinson Disease
What is being tested?
Physical Activity Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
15 Mar 2020to 31 Dec 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Neurologist confirmed clinical diagnosis for Parkinson's disease Hoehn \& Yahr stage I-III
  • Ambulatory for indoor and outdoor mobility without assistance or assistive device
  • Successful completion of Physical Activity Readiness Questionnaire (PAR-Q)26 or medical clearance from GP

Who cannot join

  • Musculoskeletal injury that would prevent participation in an exercise program
  • Other neurological disease or disorder such as stroke

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Teachers College, Columbia University

    New York, New York, 10027

Other trials in United States

About this study

Engage-PD is a single cohort evaluation of implementation of a telehealth-delivered physical activity coaching program for people with early-mid stage Parkinson's disease. The program utilizes a physical or occupational therapist to provide one-on-one coaching for individuals with early-mid stage Parkinson's disease to provide individualized structured support to facilitate and optimize exercise uptake as part of an effective self-management program. The structure of the coaching program is based on previous research in neurodegenerative disease including Parkinson's disease and Huntington's disease.

Read the detailed description

Individuals will be recruited through the Columbia University Medical Center Parkinson's Disease Center of Excellence. Individuals who choose to participate will first be given a brief evaluation, including history and contraindications for exercise, assessment of gait and balance, physical activity questionnaire (Brunel Lifestyle Inventory and International Physical Activity Questionnaire), pain questionnaire (Brief Pain Inventory), NeuroQOL quality of life assessment, and a self-efficacy measure about exercise engagement (Exercise Self Efficacy Scale). For those individuals who report low back pain, we will further administer the Modified Oswestry Low Back Pain Disability Questionnaire and a customized low back pain questionnaire. The therapist will then conduct the coaching session (see below). If this assessment is not able to be conducted in person, it will be conducted via secure videoconferencing. There will be between 1-4 follow-up phone call/videosessions and a follow-up assessments at 3 months and 6 months where all assessment will be repeated. A short questionnaire will also be administered at 3 and 6 months to assess the acceptability of the intervention.

The coaching program will utilize the Pre-Active PD program (Clinicaltrials.gov NCT03696589) to guide the delivery of the intervention. This will include a checklist of the key elements that are important for the therapist in order to facilitate PA behavior change. In addition, the therapist will utilize motivational interviewing strategies that include four processes (engaging, evoking, planning, and tracking) and five core communication skills (asking open ended questions, affirming, reflective listening, summarizing, and informing and advising). The therapist will introduce the Pre-Active PD workbook and utilize it as a tool and reference for the participant in order to engage and focus them throughout the coaching process, and will educate participants on the types of exercise options and the specific exercise benefits for PD. In the planning process, the therapist will facilitate discussion on development of specific and measurable goals, and will provide options for tracking their progress, such as written or web-based exercise logs or an activity monitor. The recommended exercises will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate-vigorous intensity aerobic exercise a minimum of three times per week. Balance and strengthening exercises will also be recommended as appropriate. At the follow up sessions (15-30 min), the therapist will review progress with the current exercise plan and progress, record if any falls have occurred and discuss barriers and facilitators for exercise engagement. Participants will also be given a short exercise safety checklist to assure safety when conducting home exercises. Participants will have the option to use a Fitbit device (Charge 4) to monitor their heart rate and physical activity during the course of the intervention period. Participants will use a study-specific login to track their progress and activity. Participants who already own a Fitbit or other activity monitor can continue to use their device during the study.

Being tested
Physical Activity Coaching
Keywords
physical activity, exercise, rehabilitation
Medical subject headings
Parkinson Disease, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity CoachingBehavioural

    Participants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period.

Study groups in NCT04922190
Study groupRoleWhat they receive
Physical Activity CoachingExperimentalParticipants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period.
Receives: Behavioral: Physical Activity Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brunel Lifestyle Physical Activity Questionnaire

    The Brunel lifestyle inventory is a 10-item questionnaire that measures both pre-planned (6 items) and un-planned (3 items) lifestyle PA. Scoring for each item is on a scale of 1-5, and the scores for each subscale are averaged. Scores range from 1 (low level of physical activity) to 5 (high level of physical activity).

    Measured: 3 months

  2. Self-Efficacy for Exercise Scale

    18-item test that measures an individual's self-efficacy to participate in exercise when numerous barriers are present, including both social and physical barriers. Total score is calculated by summing the responses to each question. This scale has a range of total scores from 0-90. A higher score indicates higher self-efficacy for exercise.

    Measured: 3 months

Secondary outcomes (7)
  1. International Physical Activity Questionnaire (Short-Form Phone version)

    Evaluates physical activity over the previous 7 days represented in MET/min per week with higher values meaning greater physical activity.

    Measured: 3 months

  2. NeuroQOL

    Patient-reported questionnaire evaluating sleep disturbances, depression, fatigue and social participation and satisfaction.

    Measured: 3 months

  3. Brief Pain Inventory

    Evaluates the presence of pain including intensity and interference with activities of daily living. Mean of the four severity items is used as measures of pain severity; the mean of the seven interference items is used as a measure of pain interference.

    Measured: 3 months

  4. Timed Up and Go

    Performance-based assessment which requires a person to stand up from a chair, walk 10 feet, turn around, return to their chair and sit back down. Outcome is measured in time (sec) to complete and higher value is worse performance.

    Measured: 3 months

  5. Standing balance assessment

    Participant will perform static standing with feet together and postural sway will be recorded with a smartphone app.

    Measured: 3 months

  6. Modified Oswestry Low Back Pain Disability Questionnaire

    Questionnaire evaluating how back pain affects everyday life (optional for those participants who report low back pain). Range 0-50 with 50 being higher level of disability.

    Measured: 3 months

  7. Acceptability questionnaire (open-ended questions)

    A short open-ended questionnaire to assess the acceptability of the intervention. These open-ended questions will be analyzed qualitatively.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start15 Mar 2020
  3. Primary completion15 Apr 2024
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04922190
Sponsor's protocol ID
20-005
Acronym
Engage-PD
Status last verified
May 2024
First submitted
4 Jun 2021
Last updated
3 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Physical Activity Coaching in people with Parkinson Disease, run by Teachers College, Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brunel Lifestyle Physical Activity Questionnaire (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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